[ FDA ENFORCEMENT INTELLIGENCE ]

Learn from the record. Every FDA recall is a quality signal.

Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.

1,000

Total recalls

217

Class I (most serious)

167

Drug

515

Device

318

Food / supplement / cosmetic

Last 12 months · latest report 2026-07-22 · source: openFDA enforcement

RECALLS BY CLASSIFICATION · MONTHLY

RECALL REASONS BY QUALITY DOMAIN

Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.

1,158 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-07-01	Class II	SURGIFY MEDICAL OYZ-2572-2026	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).	Risk Management & CAPA
2026-07-01	Class II	SURGIFY MEDICAL OYZ-2559-2026	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).	Risk Management & CAPA
2026-07-01	Class II	Acumed LLCZ-2532-2026	Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.	Risk Management & CAPA
2026-07-01	Class II	Ventec Life Systems, Inc.Z-2525-2026	Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.	—
2026-07-01	Class II	Medline Industries, LPZ-2590-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Dexcom, Inc.Z-2574-2026	Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.	Environmental Monitoring
2026-07-01	Class II	SURGIFY MEDICAL OYZ-2568-2026	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).	Risk Management & CAPA
2026-07-01	Class II	SURGIFY MEDICAL OYZ-2558-2026	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).	Risk Management & CAPA
2026-07-01	Class II	Zimmer, Inc.Z-2528-2026	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.	Risk Management & CAPA
2026-07-01	Class II	Medline Industries, LPZ-2591-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Medtronic Perfusion SystemsZ-2577-2026	During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2594-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2587-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Medtronic Perfusion SystemsZ-2576-2026	During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.	Documentation & Change Control
2026-07-01	Class II	Philips North America LlcZ-2523-2026	Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.	Documentation & Change Control
2026-07-01	Class II	Zimmer, Inc.Z-2527-2026	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.	Risk Management & CAPA
2026-07-01	Class I	Medline Industries, LPZ-2455-2026	The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.	—
2026-07-01	Class II	Medline Industries, LPZ-2585-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2588-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2581-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	SURGIFY MEDICAL OYZ-2564-2026	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).	Risk Management & CAPA
2026-07-01	Class II	SURGIFY MEDICAL OYZ-2560-2026	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).	Risk Management & CAPA
2026-07-01	Class II	SURGIFY MEDICAL OYZ-2563-2026	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).	Risk Management & CAPA
2026-06-24	Class I	Datex-Ohmeda IncZ-2358-2026	Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.	—
2026-06-24	Class II	Medline Industries, LPZ-2499-2026	During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.	Validation & Qualification

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Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.